Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,030
- 试验地点
- 114
- 主要终点
- Number of patient deaths
研究概览
简要总结
The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and for CRT device settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned de novo implantation of or upgrade to a CRT system for treatment according to the intended use
- •Patient is able to understand the nature of the registry and has provided written informed consent
- •Patient is willing and able to use the CardioMessenger and accepts the Home Monitoring concept
- •Remote monitoring using the Home Monitoring® platform is planned for the patient
排除标准
- •Standard contraindication for CRT
- •Already or previously implanted with CRT system
- •• Age < 18 years
- •Participation in another interventional clinical investigation other than the registry-based trials of BIO|STREAM.HF
- •Pregnant or breastfeeding
结局指标
主要结局
Number of patient deaths
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Number of all-cause mortality
Number of patients with cerebrovascular events
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Number of cerebrovascular events requiring hospitalization
Assessment of patients benefit from CRT
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Documentation of NYHA classification \[I-IV\]
Documentation of LVEF
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Left ventricular ejection fraction \[%\]
Number of cardiovascular adverse events
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Number of unplanned hospitalization for cardiovascular cause
Number of patients with worsening of heart failure events
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Number of unplanned hospitalization for worsening of heart failure
Number of all adverse device effects
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Number of all adverse device effects
Number of patient deaths with cardiovascular cause
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Number of patient deaths with cardiovascular cause
Number of all cause hospitalization
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Number of all cause hospitalization
Number of all device deficiencies
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Number of all device deficiencies
Documentation of LVESV
时间窗: throughout study duration, average of 3.5 years; annual evaluations
Left ventricular end-systolic volume \[ml\]
次要结局
未报告次要终点